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临床试验/NCT07154758
NCT07154758招募中不适用

Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic

Region Stockholm6 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
6
主要终点
Number of participants experiencing at least one event of treatment optimization

研究概览

简要总结

Rationale. Although several pharmacological treatments, namely renin-angiotensin-system inhibitors, sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists and sodium-glucose cotransporter-2 inhibitors, improve mortality/morbidity in heart failure with reduced ejection fraction (HFrEF), their use in clinical practice is still limited.

Aim. The aim of this project is to use the Swedish HF registry to identify HFrEF patients in need of 1) treatment implementation (initiation of treatments/uptitration), 2) screening and treatment of ID, and 3) with an indication for HF devices (CRT or ICD) but not implanted device, 4) referral for physiotherapy.

Outcomes.

Primary outcome: number of participants experiencing at least one of the following:

  1. Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)
  2. ID screening
  3. Referral for device therapy (CRT/ICD)

Secondary outcome:

  1. Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
  2. Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.
  3. Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.
  4. Number of participants screened for iron deficiency in the interventional vs. control arm.

Tertiary outcome:

1. Number of participants referred for physiotherapy in the interventional vs. control arm.

Study design. 500 patients will be screened through the Swedish Heart Failure Registry and, whether not on optimal medical treatment, implementation will be started. Outcome will be compared with a control population of 500 patients not enrolled in SwedeHF.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Registration in SwedeHF with an index date after January 1st 2023 for the screening arm. For controls, hospital access after January 1st
  • •HF duration >6 months to ensure that patients had time to go through the treatment optimization process as recommended by the guidelines.
  • •HF with reduced EF (HFrEF) defined as categorical or continuous EF ≤40%
  • •Capable of giving signed informed consent (for the screening arm)

排除标准

  • •Under optimization of HF therapy
  • •In judgment of the investigator unlikely to understand or comply with study procedures
  • •Control population is sex and age matched with the SwedeHF screening arm (1:1)

研究组 & 干预措施

Screening through SwedeHF

Experimental

HFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF

干预措施: Screening for need of HFrEF GDMT implementation through SwedeHF (Other)

Usual care

No Intervention

HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation

结局指标

主要结局

Number of participants experiencing at least one event of treatment optimization

时间窗: End of implementation for the screening arm; 1-year from index date for the control arm

Number of participants experiencing at least one of the following: 1. Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron) 2. ID screening 3. Initiation/planning for device CRT/ICD Outcome measured as variable yes/no

次要结局

  • Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.(End of implementation for the screening arm; 1-year from index date for the control arm)
  • Number of participants experiencing at least one drug initiation in the interventional vs. control arm.(End of implementation for the screening arm; 1-year from index date for the control arm)
  • Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.(End of implementation for the screening arm; 1-year from index date for the control arm)
  • Number of participants screened for iron deficiency in the interventional vs. control arm.(End of implementation for the screening arm; 1-year from index date for the control arm)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gianluigi Savarese

MD, PhD

Region Stockholm

研究点 (6)

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